Edetate Disodium Injection
» Edetate Disodium Injection is a sterile solution of Edetate Disodium in Water for Injection, which, as a result of pH adjustment, contains varying amounts of the disodium and trisodium salts. It contains the equivalent of not less than 90.0 percent and not more than 110.0 percent of the labeled amount of C10H14N2Na2O8.
Packaging and storage— Preserve in single-dose containers, preferably of Type I glass.
Identification— Transfer a volume of Injection, equivalent to about 1 g of edetate disodium, to an evaporating dish, adjust with 3 N hydrochloric acid to a pH of 5.0, and evaporate on a steam bath to dryness: the residue responds to Identification tests A and C under Edetate Disodium.
Bacterial endotoxins 85 It contains not more than 0.2 USP Endotoxin Unit per mg of edetate disodium.
pH 791: between 6.5 and 7.5.
Other requirements— It meets the requirements under Injections 1.
Assay preparation— Dilute an accurately measured volume of Injection, equivalent to about 2 g of edetate disodium, with water to volume in a 100-mL volumetric flask, and mix.
Procedure— Proceed as directed for Procedure in the Assay under Edetate Disodium. Calculate the weight, in mg, of C10H14N2Na2O8 in the volume of Injection taken by the formula:
(336.21/100.09)W(VT /V)
in which 336.21 and 100.09 are the molecular weights of edetate disodium and calcium carbonate, respectively; W is the weight, in mg, of calcium carbonate; VT is the volume, in mL, of the Assay preparation; and V is the volume, in mL, of the Assay preparation consumed in the titration.
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